LINCOLN, NE, April 15 /PRNewswire/ - The acceptance of Peros' oral delivery platform and vaccine facility by the USDA marks another significant achievement by Benchmark Biolabs, a full service biopharmaceutical product development firm.
Benchmark Biolabs designed, constructed and oversees the operation and management of the Peros production facility which is co-located on Benchmark's R&D and manufacturing biotechnology campus in Lincoln, NE.
By obtaining approval by the USDA, Peros, a pioneering biotechnology company that has developed unique natural product formulation methods enabling oral delivery of biopharmaceutical compounds, is now well positioned to begin product commercialization of its oral delivery platform.
"Had it not been for Benchmark's stage-gated "BEAM(TM)" approach to our project from validation to licensure, our technology would have been yet another promising biotech discovery that would never have reached its commercial potential.", stated Dr. Grant Vandenberg, CSO and Founder of Peros.
Benchmark and Peros are excited to offer this first-in-class oral delivery technology platform that will significantly enhance the actual value of vaccines. The licensed platform offers a labor minimizing, practical method for oral delivery of prophylactic and therapeutic products for the livestock industry as well as traditional animal health company opportunities to expand the oral enablement of the industry as a whole.
"Benchmark's mission is to design and implement, with our clients, an efficient product development process - delivering critical expertise, technologies, facilities, ideas and services, in a seamless and integrated offering", added Tom Overbay, Vice-President of Business Development for Benchmark Biolabs.
Peros' licensure marks another significant and innovative first obtained by Benchmark over their 11-year history. At the Benchmark campus there are now three licensed manufacturing facilities which were designed, built, and managed using the BEAM(TM) model for enabling biotechnology in stage-gated manner. Each of these facilities sprang from a novel, unique technology which was heavily reliant on the development process offered by Benchmark. Along with development of traditional biologicals, Benchmark has been intimately involved with molecular farming to produce a parasite vaccine and commercial development of a tissue culture based plant-derived recombinant protein production system..
"Enabling technology is not specific to the nature of an asset but rather to the focused and prioritized implementation of key regulatory steps toward commercialization. In addition to the routine business at Benchmark Biolabs, we have initiated the setup and operation of five separate biotech institutions covering a wide array of biotechniques, molecules, and regulatory compliance. That is a new company nearly every 2 years since the inception of Benchmark Biolabs and demonstrates the business niche of enabling bio-molecules rather than simply discovering them." said Tim Miller, President of Benchmark Biolabs.
Benchmark Biolabs is a biopharmaceutical product development firm with over a decade of success in the validation and development of biologicals. Benchmark applies a unique mindset to the development process, offering a modern business strategy aimed at integrating the entire process, from Concept to Commercialization.
Benchmark's team provides analytical, clinical, (including a BSL-3) custom laboratory, regulatory process development, manufacturing and QC services in order to enhance the optimal data sets and efficiency of product development for our clients.
|SOURCE Benchmark Biolabs|
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